Feasibility of Remote Evaluation and Monitoring of Acoustic Pathophysiological Signals With External Sensor Technology

NCT ID: NCT04693091

Last Updated: 2021-01-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-28
• Study Completion Date: 2021-04-30

Brief Summary

The aim of this study is to explore the acceptability and feasibility of a novel medical device system for remote monitoring of breath and heart sounds (replicating remotely, and in an easy-to-use garment, that which a clinician would do with their stethoscope to listen to a patient's chest, by evaluating sounds captured through a wearable device (Senti)). As a first-in-man study, the investigators will investigate the safety of the Senti device, the usability and acceptability of the device; and ensure technical and practical feasibility of the device in a real-world clinical setting.

10 patients will be recruited (the study participants) in two tranches (6 and 4) who are being discharged from A&E into the care of the community respiratory team. These patients will wear the Senti device. The first tranche will use the device over a single session lasting 20 minutes only. The second tranche (which will include patients from tranche one, and which will only proceed if no adverse events are detected in tranche one), participants will wear the device at their discretion (particularly encouraged to wear overnight) over the course of 5 days. The investigators will survey the study participants to answer three key questions:

1. What is the feasibility of the Senti data-capture device?

2. Is this device usable in clinical practice?

3. What are the requirements to train patients to use the device?

The investigators will also consider:

4. Does the device function technically and practically, in real-world clinical scenarios?

5. What are the key expected and unexpected safety issues related to using the device (with a particular emphasis on whether the device is likely to cause pressure sores).

These questions will establish the feasibility of using the Senti data capture device as part of a novel medical device system for the autonomous evaluation and monitoring of bioacoustic signals.

Detailed Description

TITLE: Remote Evaluation and Monitoring of Acoustic Pathophysiological parameters with external sensor technology.

DESIGN: First-In-Man and Feasibility study of the Senti Version 1 Device.

AIMS: To explore the acceptability and feasibility of a novel medical device for the remote monitoring and evaluation of acoustic pathophysiological parameters. - To investigate usability and acceptability of the Senti data capture device, and to ensure technical and practical functionality of the device in a real-world clinical scenario.

PRIMARY OUTCOMES: Device feasibility SECONDARY OUTCOMES: Length of time with the device in situ. The ease with which patients can apply the device.

POPULATION ELIGIBILITY: Patients being discharged home with community respiratory team support, after attending A&E.

DURATION: 3 Months. (Recruitment period: 2 months. Analysis and reporting: 1 month).

Conditions

Respiratory Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Senti Arm

In stage 1 of this study (6 patients), the patient will apply the device and complete the initial patient survey; questions are around usability, comfort (including feelings of pressure), and acceptability. The Investigator will record the time taken to apply the device. A brief 30 seconds of chest sounds will be recorded from each of the nine sensors on the device in three different settings: standing up, lying down, walking around.

In stage 2 of this study (10 patients; 6 of whom would be re-recruited from the first stage), the participant will use the device at home over five days. The Investigator will assess the participant daily for any signs of pressure sores or complications from using the device (including topical allergic reactions). The participant will complete a daily survey. The participant is encouraged to remove the device and apply it at their discretion. The participant can opt-out of wearing the device at any stage.

Group Type: EXPERIMENTAL

Senti V1.0 Device

Intervention Type: DEVICE

This device class I, CE marked garment, with a similar form to a T-Shirt, embedded with ten sensor modules encased in silicone; the device comes with a charging stand in the form of a clothes hanger. Depending on the outcome of this feasibility study, the device may, in the future, form part of a class IIb medical device system, when accompanied by cloud-based software to listen to both current and historically recorded breath sounds for each Senti patient. The Senti Version One device will be labelled clearly to indicate the device version, on the inside of the garment, conforming to the MDR.

The garment itself will be made from textile composite, including cotton, elastase, micromodel, spandex, and polyester. All other components (including electronic and other plastic components) will be entirely encased in medical-grade silicone.

Interventions

Senti V1.0 Device

This device class I, CE marked garment, with a similar form to a T-Shirt, embedded with ten sensor modules encased in silicone; the device comes with a charging stand in the form of a clothes hanger. Depending on the outcome of this feasibility study, the device may, in the future, form part of a class IIb medical device system, when accompanied by cloud-based software to listen to both current and historically recorded breath sounds for each Senti patient. The Senti Version One device will be labelled clearly to indicate the device version, on the inside of the garment, conforming to the MDR.

The garment itself will be made from textile composite, including cotton, elastase, micromodel, spandex, and polyester. All other components (including electronic and other plastic components) will be entirely encased in medical-grade silicone.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients attending A&E who are being discharged from A&E into the care of the community respiratory team.

Exclusion Criteria

• Patients unable to give their consent.
• Patients with a known sensitivity or allergy to any of the components of the device.
• Patients with any active implanted devices (such as pacemakers or vagal nerve stimulators).
• Patients with existing pressure sores across the area this device would come into contact (predominantly, across the thorax).
• Patients with significant cognitive impairment or limiting physical disabilities - to the extent that they are not able to manage their own ADLs; except where sufficient family or care support is available to manage the device functions (in which case, the device may be used with caution).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Senti Tech Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Senti Tech

Liverpool, Merseyside, United Kingdom

Countries

United Kingdom

Central Contacts

Philip Alton, Mb ChB

Role: CONTACT

phil.alton@senti.care

+447724129546

Other Identifiers

Senti-REMAP-WEST-FEA-1

Identifier Type: -

Identifier Source: org_study_id